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Social Media And Risk-reduction Training for Infant Care Practices (SMART) (SMART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01713868
Recruitment Status : Completed
First Posted : October 25, 2012
Results First Posted : January 3, 2019
Last Update Posted : January 11, 2019
Sponsor:
Collaborators:
Yale University
Boston University
Information provided by (Responsible Party):
Rachel Moon, MD, University of Virginia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Risk Reduction
Interventions Behavioral: Safe Sleep Nursery Education
Behavioral: Breastfeeding Nursery Education
Behavioral: Breastfeeding Mobile Health Messaging
Behavioral: Safe Sleep Mobile Health Messaging
Enrollment 1600
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Safe Sleep Edu and Breastfeeding mHealth Breastfeeding Edu and Safe Sleep mHealth Safe Sleep Edu and Safe Sleep mHealth Breastfeed Edu and Breastfeed mHealth
Hide Arm/Group Description

Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging

Safe Sleep Nursery Education: Nursery-based program for safe sleep

Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.

Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging

Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding

Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.

Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging

Safe Sleep Nursery Education: Nursery-based program for safe sleep

Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.

Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging

Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding

Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.

Period Title: Overall Study
Started 400 400 400 400
Completed 303 335 320 305
Not Completed 97 65 80 95
Arm/Group Title Safe Sleep Edu and Breastfeeding mHealth Breastfeeding Edu and Safe Sleep mHealth Safe Sleep Edu and Safe Sleep mHealth Breastfeed Edu and Breastfeed mHealth Total
Hide Arm/Group Description

Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging

Safe Sleep Nursery Education: Nursery-based program for safe sleep

Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.

Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging

Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding

Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.

Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging

Safe Sleep Nursery Education: Nursery-based program for safe sleep

Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.

Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging

Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding

Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.

Total of all reporting groups
Overall Number of Baseline Participants 400 400 400 400 1600
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 400 participants 400 participants 400 participants 400 participants 1600 participants
<=18 years
32
   8.0%
14
   3.5%
42
  10.5%
21
   5.3%
109
   6.8%
Between 18 and 65 years
368
  92.0%
386
  96.5%
358
  89.5%
379
  94.8%
1491
  93.2%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 400 participants 400 participants 400 participants 400 participants 1600 participants
27.0  (5.9) 29.3  (5.8) 27.1  (5.9) 27.6  (5.7) 27.9  (5.6)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 303 participants 335 participants 320 participants 305 participants 1263 participants
Female
303
 100.0%
335
 100.0%
320
 100.0%
305
 100.0%
1263
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: Number of participants with data to analyze differed from the number of participants recruited because of attrition.
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 400 participants 400 participants 400 participants 400 participants 1600 participants
Hispanic or Latino
128
  32.0%
121
  30.3%
144
  36.0%
127
  31.8%
520
  32.5%
Not Hispanic or Latino
272
  68.0%
279
  69.8%
256
  64.0%
273
  68.3%
1080
  67.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 400 participants 400 participants 400 participants 400 participants 1600 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
12
   3.0%
26
   6.5%
6
   1.5%
20
   5.0%
64
   4.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
173
  43.3%
101
  25.3%
95
  23.8%
133
  33.3%
502
  31.4%
White
112
  28.0%
205
  51.2%
187
  46.8%
141
  35.3%
645
  40.3%
More than one race
20
   5.0%
11
   2.8%
7
   1.8%
8
   2.0%
46
   2.9%
Unknown or Not Reported
83
  20.8%
57
  14.2%
105
  26.3%
98
  24.5%
343
  21.4%
Maternal educational level   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 303 participants 335 participants 320 participants 305 participants 1263 participants
Less than high school
36
  11.9%
11
   3.3%
31
   9.7%
10
   3.3%
88
   7.0%
High school or GED
84
  27.7%
63
  18.8%
77
  24.1%
88
  28.9%
312
  24.7%
Some college
102
  33.7%
114
  34.0%
118
  36.9%
104
  34.1%
438
  34.7%
College or more
80
  26.4%
147
  43.9%
92
  28.7%
101
  33.1%
420
  33.3%
Unknown
1
   0.3%
0
   0.0%
2
   0.6%
2
   0.7%
5
   0.4%
[1]
Measure Analysis Population Description: Because of attrition, number analyzed is less than number recruited.
Household income   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 303 participants 335 participants 320 participants 305 participants 1263 participants
Less than $20,000
49
  16.2%
30
   9.0%
55
  17.2%
47
  15.4%
181
  14.3%
$20,000-49.999
59
  19.5%
62
  18.5%
56
  17.5%
62
  20.3%
239
  18.9%
$50,000 or more
81
  26.7%
175
  52.2%
91
  28.4%
88
  28.9%
435
  34.4%
Unknown
114
  37.6%
68
  20.3%
118
  36.9%
108
  35.4%
408
  32.3%
[1]
Measure Analysis Population Description: Because of attrition, number analyzed is less than number recruited
Maternal marital status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 303 participants 335 participants 320 participants 305 participants 1263 participants
Married
127
  41.9%
203
  60.6%
147
  45.9%
163
  53.4%
640
  50.7%
Never married
158
  52.1%
111
  33.1%
151
  47.2%
132
  43.3%
552
  43.7%
Divorced, separated, or widowed
14
   4.6%
20
   6.0%
14
   4.4%
8
   2.6%
56
   4.4%
Unknown
4
   1.3%
1
   0.3%
8
   2.5%
2
   0.7%
15
   1.2%
[1]
Measure Analysis Population Description: Because of attrition, number analyzed is less than number recruited
1.Primary Outcome
Title Adherence With Recommended Supine Sleep Position
Hide Description Hypothesis:For supine sleep position, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Results analyzed at 2+ months infant age.
Arm/Group Title Safe Sleep Edu and Breastfeeding mHealth Breastfeeding Edu and Safe Sleep mHealth Safe Sleep Edu and Safe Sleep mHealth Breastfeed Edu and Breastfeed mHealth
Hide Arm/Group Description:

Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging

Safe Sleep Nursery Education: Nursery-based program for safe sleep

Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.

Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging

Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding

Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.

Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging

Safe Sleep Nursery Education: Nursery-based program for safe sleep

Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.

Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging

Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding

Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.

Overall Number of Participants Analyzed 301 333 319 303
Measure Type: Count of Participants
Unit of Measure: Participants
Usual supine sleep position
230
  76.4%
294
  88.3%
294
  92.2%
243
  80.2%
Usual nonsupine position
71
  23.6%
39
  11.7%
25
   7.8%
60
  19.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Safe Sleep Edu and Breastfeeding mHealth, Breastfeeding Edu and Safe Sleep mHealth, Safe Sleep Edu and Safe Sleep mHealth, Breastfeed Edu and Breastfeed mHealth
Comments Sample size provided power of detecting the effect of an individual intervention in the presence of interaction.We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.
Type of Statistical Test Superiority
Comments GEE logistic regression accounted for within-hospital clustering, individual-level & hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was significant, we presented results from the interaction model.
Statistical Test of Hypothesis P-Value 0.03
Comments Adjusted education effect p=0.34. Adjusted mHealth effect p<0.001. Test for interaction p=0.01. Adjusted education only effect p=0.74. Adjusted mHealth only effect p=0.02. Adjusted mHealth and education effect: p=0.03
Method Regression, Logistic
Comments [Not Specified]
2.Primary Outcome
Title Adherence With Recommended Roomsharing Without Bed Sharing
Hide Description Hypothesis: For roomsharing without bed sharing, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Safe Sleep Edu and Breastfeeding mHealth Breastfeeding Edu and Safe Sleep mHealth Safe Sleep Edu and Safe Sleep mHealth Breastfeed Edu and Breastfeed mHealth
Hide Arm/Group Description:

Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging

Safe Sleep Nursery Education: Nursery-based program for safe sleep

Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.

Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging

Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding

Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.

Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging

Safe Sleep Nursery Education: Nursery-based program for safe sleep

Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.

Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging

Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding

Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.

Overall Number of Participants Analyzed 293 328 313 291
Measure Type: Count of Participants
Unit of Measure: Participants
Roomsharing without bedsharing
218
  74.4%
262
  79.9%
269
  85.9%
205
  70.4%
Not roomsharing without bedsharing
75
  25.6%
66
  20.1%
44
  14.1%
86
  29.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Safe Sleep Edu and Breastfeeding mHealth, Breastfeeding Edu and Safe Sleep mHealth, Safe Sleep Edu and Safe Sleep mHealth, Breastfeed Edu and Breastfeed mHealth
Comments Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p<0.05). Allowing for 20% loss to follow-up,this led to a sample of n=1600.
Type of Statistical Test Superiority
Comments GEE logistic regression accounted for within-hospital clustering, individual-level & hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.
Statistical Test of Hypothesis P-Value <0.001
Comments Adjusted education effect: p=0.22. Adjusted mHealth effect p<0.001. Test for interaction p=0.08.
Method Regression, Logistic
Comments [Not Specified]
3.Primary Outcome
Title Adherence With Recommended Pacifier Use
Hide Description Hypothesis: For pacifier use, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Safe Sleep Edu and Breastfeeding mHealth Breastfeeding Edu and Safe Sleep mHealth Safe Sleep Edu and Safe Sleep mHealth Breastfeed Edu and Breastfeed mHealth
Hide Arm/Group Description:

Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging

Safe Sleep Nursery Education: Nursery-based program for safe sleep

Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.

Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging

Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding

Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.

Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging

Safe Sleep Nursery Education: Nursery-based program for safe sleep

Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.

Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging

Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding

Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.

Overall Number of Participants Analyzed 290 326 315 291
Measure Type: Count of Participants
Unit of Measure: Participants
Usual pacifier use
193
  66.6%
226
  69.3%
240
  76.2%
174
  59.8%
Usual no pacifier use
97
  33.4%
100
  30.7%
75
  23.8%
117
  40.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Safe Sleep Edu and Breastfeeding mHealth, Breastfeeding Edu and Safe Sleep mHealth, Safe Sleep Edu and Safe Sleep mHealth, Breastfeed Edu and Breastfeed mHealth
Comments Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.
Type of Statistical Test Superiority
Comments GEE logistic regression accounted for within-hospital clustering, individual-level & hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.
Statistical Test of Hypothesis P-Value <0.001
Comments Adjusted education effect p=0.07. Adjusted mHealth effect p<0.001. Test for interaction p=0.54
Method Regression, Logistic
Comments [Not Specified]
4.Primary Outcome
Title Adherence With Recommended Avoiding Use of Soft Bedding
Hide Description Hypothesis: For each recommended avoidance of soft bedding use, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Safe Sleep Edu and Breastfeeding mHealth Breastfeeding Edu and Safe Sleep mHealth Safe Sleep Edu and Safe Sleep mHealth Breastfeed Edu and Breastfeed mHealth
Hide Arm/Group Description:

Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging

Safe Sleep Nursery Education: Nursery-based program for safe sleep

Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.

Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging

Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding

Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.

Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging

Safe Sleep Nursery Education: Nursery-based program for safe sleep

Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.

Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging

Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding

Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.

Overall Number of Participants Analyzed 300 333 320 299
Measure Type: Count of Participants
Unit of Measure: Participants
No soft bedding use
204
  68.0%
259
  77.8%
262
  81.9%
202
  67.6%
Soft bedding use
96
  32.0%
74
  22.2%
58
  18.1%
97
  32.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Safe Sleep Edu and Breastfeeding mHealth, Breastfeeding Edu and Safe Sleep mHealth, Safe Sleep Edu and Safe Sleep mHealth, Breastfeed Edu and Breastfeed mHealth
Comments Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.
Type of Statistical Test Superiority
Comments GEE logistic regression accounted for within-hospital clustering, individual-level & hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.
Statistical Test of Hypothesis P-Value <0.001
Comments Adjusted education effect p=0.33. Adjusted mHealth effect p<0.001. Test for interaction p=0.29.
Method Regression, Logistic
Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants Reporting Positive/Nonpositive Attitudes Towards Supine Sleep
Hide Description Questions assessing attitudes toward sleep position included the mothers' ratings regarding if she believed that each infant sleep position (back, side, stomach) made the baby healthy, safer, more comfortable, and kept the baby from choking. Positive attitudes were defined as having positive attitudes toward the recommended behavior AND not having positive attitudes toward other behaviors (e.g., having positive attitudes towards both supine and side sleep would lead to a categorization of not having positive attitudes towards supine sleep only).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All 4 arms received a combination of education (breastfeeding or safe sleep) and mHealth (breastfeeding or safe sleep). Only the mHealth interventions were effective. Thus, for this analysis, we collapsed the arms to 2 arms: received mHealth breastfeeding and received mHealth safe sleep.
Arm/Group Title Control mHealth Safe Sleep
Hide Arm/Group Description:
Received mHealth breastfeeding
Received mHealth safe sleep
Overall Number of Participants Analyzed 608 655
Measure Type: Count of Participants
Unit of Measure: Participants
# reporting positive attitudes re supine sleep
313
  51.5%
491
  75.0%
# reporting nonpositive attitudes re supine sleep
295
  48.5%
164
  25.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, mHealth Safe Sleep
Comments [Not Specified]
Type of Statistical Test Other
Comments Causal mediation analysis
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 0.16
Estimation Comments [Not Specified]
Other Statistical Analysis We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.
6.Secondary Outcome
Title Number of Participants Reporting Positive/Nonpositive Attitudes Towards Roomsharing Without Bedsharing.
Hide Description Questions assessing attitudes toward sleep location (bedsharing, roomsharing without bedsharing) assessed whether the location was pleasant for the baby and/or mother, safer for the baby, more comfortable for the baby and/or mother, and kept the baby from choking. Positive attitudes were defined as having positive attitudes toward the recommended behavior AND not having positive attitudes toward other behaviors (e.g., having positive attitudes towards both bedsharing and not bedsharing would lead to a categorization of not having positive attitudes towards bedsharing only).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All 4 arms received a combination of education (breastfeeding or safe sleep) and mHealth (breastfeeding or safe sleep). Only the mHealth interventions were effective. Thus, for this analysis, we collapsed the arms to 2 arms: received mHealth breastfeeding and received mHealth safe sleep.
Arm/Group Title Control mHealth Safe Sleep
Hide Arm/Group Description:
Received mHealth breastfeeding
Received mHealth safe sleep
Overall Number of Participants Analyzed 608 655
Measure Type: Count of Participants
Unit of Measure: Participants
Positive attitude re: roomsharing w/o bedsharing
306
  50.3%
442
  67.5%
Nonpositive attitude re roomsharing w/o bedsharing
302
  49.7%
213
  32.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, mHealth Safe Sleep
Comments [Not Specified]
Type of Statistical Test Other
Comments Causal mediation analysis
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 0.14
Estimation Comments [Not Specified]
Other Statistical Analysis We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.
7.Secondary Outcome
Title Number of Participants Reporting Positive/Nonpositive Social Norms re Supine Sleep
Hide Description Social norms were assessed by asking if the people most important to the mother thought that the baby should sleep in each position or location. Positive social norms were defined as having positive norms toward the recommended behavior AND not having positive norms toward other behaviors.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All 4 arms received a combination of education (breastfeeding or safe sleep) and mHealth (breastfeeding or safe sleep). Only the mHealth interventions were effective. Thus, for this analysis, we collapsed the arms to 2 arms: received mHealth breastfeeding and received mHealth safe sleep
Arm/Group Title Control mHealth Safe Sleep
Hide Arm/Group Description:
Received mHealth breastfeeding
Received mHealth safe sleep
Overall Number of Participants Analyzed 608 655
Measure Type: Count of Participants
Unit of Measure: Participants
Positive social norms re supine sleep
332
  54.6%
466
  71.1%
Nonpositive social norms re supine sleep
276
  45.4%
189
  28.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, mHealth Safe Sleep
Comments [Not Specified]
Type of Statistical Test Other
Comments Causal mediation analysis
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 0.14
Estimation Comments [Not Specified]
Other Statistical Analysis We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.
8.Secondary Outcome
Title Number of Participants Reporting Positive/Nonpositive Social Norms re: Roomsharing Without Bedsharing.
Hide Description Social norms were assessed by asking if the people most important to the mother thought that the baby should sleep in each position or location. Positive social norms were defined as having positive norms toward the recommended behavior AND not having positive norms toward other behaviors
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All 4 arms received a combination of education (breastfeeding or safe sleep) and mHealth (breastfeeding or safe sleep). Only the mHealth interventions were effective. Thus, for this analysis, we collapsed the arms to 2 arms: received mHealth breastfeeding and received mHealth safe sleep.
Arm/Group Title Control mHealth Safe Sleep
Hide Arm/Group Description:
Received mHealth breastfeeding
Received mHealth safe sleep
Overall Number of Participants Analyzed 608 655
Measure Type: Count of Participants
Unit of Measure: Participants
Positive social norms re roomsharing w/o bedsharin
297
  48.8%
350
  53.4%
Nonpositive norms re roomsharing w/o bedsharing
311
  51.2%
305
  46.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, mHealth Safe Sleep
Comments [Not Specified]
Type of Statistical Test Other
Comments Causal mediation analysis
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 0.15
Estimation Comments [Not Specified]
Other Statistical Analysis We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.
Time Frame 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Safe Sleep Edu and Breastfeeding mHealth Breastfeeding Edu and Safe Sleep mHealth Safe Sleep Edu and Safe Sleep mHealth Breastfeed Edu and Breastfeed mHealth
Hide Arm/Group Description

Participants will receive Safe Sleep Nursery Education and Breastfeeding Mobile Health messaging

Safe Sleep Nursery Education: Nursery-based program for safe sleep

Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.

Participants will receive the Breastfeeding Nursery Education and the Safe Sleep Mobile Health messaging

Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding

Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.

Participants will receive Safe Sleep Nursery Education and Safe Sleep Mobile Health messaging

Safe Sleep Nursery Education: Nursery-based program for safe sleep

Safe Sleep Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.

Participants will receive Breastfeeding Nursery Education and Breastfeeding Mobile Health messaging

Breastfeeding Nursery Education: Nursery-based program to promote breastfeeding

Breastfeeding Mobile Health Messaging: Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.

All-Cause Mortality
Safe Sleep Edu and Breastfeeding mHealth Breastfeeding Edu and Safe Sleep mHealth Safe Sleep Edu and Safe Sleep mHealth Breastfeed Edu and Breastfeed mHealth
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/400 (0.00%)   0/400 (0.00%)   0/400 (0.00%)   0/400 (0.00%) 
Hide Serious Adverse Events
Safe Sleep Edu and Breastfeeding mHealth Breastfeeding Edu and Safe Sleep mHealth Safe Sleep Edu and Safe Sleep mHealth Breastfeed Edu and Breastfeed mHealth
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/400 (0.00%)   0/400 (0.00%)   0/400 (0.00%)   0/400 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Safe Sleep Edu and Breastfeeding mHealth Breastfeeding Edu and Safe Sleep mHealth Safe Sleep Edu and Safe Sleep mHealth Breastfeed Edu and Breastfeed mHealth
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/400 (0.00%)   0/400 (0.00%)   0/400 (0.00%)   0/400 (0.00%) 
There was a 21% loss to follow-up, not generalizable to non-English-speaking populations, not powered to assess adverse events, did not measure clinical outcomes (i.e., rates of sudden unexpected infant death), and the results were self-reported
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Corwin, MD
Organization: Boston University
EMail: mjcorwin@bu.edu
Layout table for additonal information
Responsible Party: Rachel Moon, MD, University of Virginia
ClinicalTrials.gov Identifier: NCT01713868    
Other Study ID Numbers: 1R01HD072815-01 ( U.S. NIH Grant/Contract )
First Submitted: October 19, 2012
First Posted: October 25, 2012
Results First Submitted: November 14, 2018
Results First Posted: January 3, 2019
Last Update Posted: January 11, 2019